Browsing by Author "Knopf, Amelia S."

Now showing 1 - 6 of 6
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    Adolescent Self-Consent for Biomedical HIV Prevention Research: Implications for Institutional Review Board Approval and Implementation
    (Elsevier, 2015-07) Gilbert, Amy Lewis; Knopf, Amelia S.; Fortenberry, J. Dennis; Hosek, Sybil G.; Kapogiannis, Bill G.; Zimet, Gregory D.; IU School of Nursing
    Purpose The Adolescent Medicine Trials Network Protocol 113 (ATN113) is an open-label, multisite demonstration project and Phase II safety study of human immunodeficiency virus (HIV) preexposure prophylaxis with 15- to 17-year-old young men who have sex with men that requires adolescent consent for participation. The purpose of this study was to examine factors related to the process by which Institutional Review Boards (IRBs) and researchers made decisions regarding whether to approve and implement ATN113 so as to inform future biomedical HIV prevention research with high-risk adolescent populations. Methods Participants included 17 researchers at 13 sites in 12 states considering ATN113 implementation. Qualitative descriptive methods were used. Data sources included interviews and documents generated during the initiation process. Results A common process for initiating ATN113 emerged, and informants described how they identified and addressed practical, ethical, and legal challenges that arose. Informants described the process as responding to the protocol, preparing for IRB submission, abstaining from or proceeding with submission, responding to IRB concerns, and reacting to the outcomes. A complex array of factors impacting approval and implementation were identified, and ATN113 was ultimately implemented in seven of 13 sites. Informants also reflected on lessons learned that may help inform future biomedical HIV prevention research with high-risk adolescent populations. Conclusions The results illustrate factors for consideration in determining whether to implement such trials, demonstrate that such protocols have the potential to be approved, and highlight a need for clearer standards regarding biomedical HIV prevention research with high-risk adolescent populations.
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    Avoiding a Tyranny of the Majority: Public Deliberation as Citizen Science, Sensitive Issues, and Vulnerable Populations
    (Taylor & Francis, 2019) Ott, Mary A.; Knopf, Amelia S.; Pediatrics, School of Medicine
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    Measuring research mistrust in adolescents and adults: Validity and reliability of an adapted version of the Group-Based Medical Mistrust Scale
    (PLOS, 2021-01-22) Knopf, Amelia S.; Krombach, Peter; Katz, Amy J.; Baker, Rebecca; Zimet, Gregory; School of Nursing
    Mistrust of health care providers among persons of color is a significant barrier to engaging them in research studies. Underrepresentation of persons of color is particularly problematic when the health problem under study disproportionately affects minoritized communities. The purpose of this study was to test the validity and reliability of an abbreviated and adapted version of the Group Based Medical Mistrust Scale. The GBMMS is a 12-item scale with three subscales that assess suspicion, experiences of discrimination, and lack of support in the health care setting. To adapt for use in the research setting, we shortened the scale to six items, and replaced "health care workers" and "health care" with "medical researchers" and "medical research," respectively. Using panelists from a market research firm, we recruited and enrolled a racially and ethnically diverse sample of American adults (N = 365) and adolescents aged 14-17 (N = 250). We administered the adapted scale in a web-based survey. We used Cronbach's alpha to evaluate measure internal reliability of the scale and external factor analysis to evaluate the relationships between the revised scale items. Five of the six items loaded onto a single factor, with (α = 0.917) for adolescents and (α = 0.912) for adults. Mean scores for each item ranged from 2.5-2.9, and the mean summary score (range 6-25) was 13.3 for adults and 13.1 for adolescents. Among adults, Black respondents had significantly higher mean summary scores compared to whites and those in other racia/ethnic groups (p<0.001). There was a trend toward significance for Black adolescents as compared to white respondents and those in other racial/ethnic groups (p = 0.09). This five-item modified version of the GBMMS is reliable and valid for measuring research mistrust with American adults and adolescents of diverse racial and ethnic identities.
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    Minors' and Young Adults' Experiences of the Research Consent Process in a Phase II Safety Study of Pre-exposure Prophylaxis for HIV
    (Elsevier, 2017-12) Knopf, Amelia S.; Ott, Mary A.; Liu, Nancy; Kapogiannis, Bill G.; Zimet, Gregory D.; Fortenberry, J. Dennis; Hosek, Sybil G.; School of Nursing
    PURPOSE: There is a persistent HIV epidemic among sexual and gender minority adolescents in the U.S. Oral pre-exposure prophylaxis (PrEP) is an efficacious prevention strategy, but not yet approved for minors. Minors' access to biomedical HIV prevention technologies is impeded by the ethical and legal complexities of consent to research participation. We explore autonomous consent and study experiences among minor and adult participants in Project PrEPare, a Phase II safety study of PrEP for HIV prevention. METHODS: Data for this mixed-methods descriptive study were collected via self-administered web-survey and in-depth telephone interviews in early 2016. Eligible participants were previously enrolled in Project PrEPare. We attempted to contact 191 participants; 74 were reached and expressed interest in participating and 58 enrolled. RESULTS: Participants nearly universally felt well informed, understood the study, and freely volunteered with the clear understanding they could withdraw any time. All felt supported by study staff, but a small minority wished for more support during enrollment. Minors were more likely than adults to indicate a wish for more support in decision-making, and adults expressed higher satisfaction with their decision compared to minors. There was no association between elements of consent and Project PrEPare study outcomes. CONCLUSIONS: Participants had an overwhelmingly positive experience in a Phase II safety study of PrEP for HIV prevention. Some minors wished for more support during the decision-making process, but none consulted their parents about the decision. Our results support the inclusion of decisional supports in consent processes for adolescents, while also protecting their privacy.
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    Moral conflict and competing duties in the initiation of a biomedical HIV prevention trial with minor adolescents
    (Taylor & Francis, 2017-07) Knopf, Amelia S.; Gilbert, Amy Lewis; Zimet, Gregory D.; Kapogiannis, Bill G.; Hosek, Sybil G.; Fortenberry, J. Dennis; Ott, Mary A.; The Adolescent Medicine Trials Network for HIV/AIDS Interventions; School of Nursing
    BACKGROUND: Biomedical HIV prevention research with minors is complicated by the requirement of parental consent, which may disclose sensitive information to parents. We examine the experience of principal investigators (PIs) and study personnel who faced this complex ethical issue in the first biomedical HIV prevention study that allowed minors to self-consent for enrollment. METHODS: We conducted in-depth interviews with PIs and study personnel from 13 medical trial sites in cities across the United States. Data were analyzed using a conventional content analysis. RESULTS: Participants experienced moral conflict as they struggled to fulfill conflicting duties in this trial involving minor adolescents with multiple vulnerabilities. Our participants experienced conflict between the two types of duties-protective and scientific-previously identified by Merritt. Protective duties were owed to the child, the parents, and the institution, and participants expressed tension between the actions that would protect these subgroups and the actions necessary to fulfill their scientific duties. CONCLUSIONS: Moral conflict was resolved in a variety of ways, including reflecting on the protocol's alignment with federal regulations, modifying consent language, considering each individual for enrollment carefully, and accepting institutional review board (IRB) decisions. Potential solutions for future studies are discussed, and include flexible protocol consent procedures and centralized IRB reviews.
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    Sexual learning among East African adolescents in the context of generalized HIV epidemics: A systematic qualitative meta-synthesis
    (PLOS, 2017-03-09) Knopf, Amelia S.; McNealy, Kim R.; Al-Khattab, Halima; Carter-Harris, Lisa; Oruche, Ukamaka M.; Naanyu, Violet; Burke Draucker, Claire; IU School of Nursing
    Background AIDS-related illness is the leading cause of mortality for adolescents in sub-Saharan Africa. Together, Kenya, Tanzania, and Uganda account for 21% of HIV-infected adolescents in sub-Saharan Africa. The United Nations framework for addressing the epidemic among adolescents calls for comprehensive sexual and reproductive health education. These HIV prevention efforts could be informed by a synthesis of existing research about the formal and informal sexual education of adolescents in countries experiencing generalized epidemics. The purpose of this study was to describe the process of sexual learning among East African adolescents living in the context of generalized HIV epidemics. Methods Qualitative metasynthesis, a systematic procedure for integrating the results of multiple qualitative studies addressing a similar phenomenon, was used. Thirty-two research reports met study inclusion criteria. The reports were assessed in a four-step analytic process: appraisal, classification of findings, synthesis of findings, and construction of a framework depicting the process of sexual learning in this population. Results The framework includes three phases of sexual learning: 1) being primed for sex, 2) making sense of sex, and 3) having sexual experiences. Adolescents were primed for sex through gender norms, cultural practices, and economic structures as well as through conversations and formal instruction. They made sense of sex by acquiring information about sexual intercourse, reproduction and pregnancy, sexually transmitted infections, and relationships and by developing a variety of beliefs and attitudes about these topics. Some adolescents described having sexual experiences that met wants or needs, but many experienced sex that was coerced or violent. Whether sex was wanted, coerced, or violent, adolescents experienced worry about sexually transmitted infections or premarital pregnancy. Conclusions The three phases of sexual learning interact to shape adolescents’ sexual lives and their risk for HIV infection. This framework will contribute to the development of sexual education programs that address HIV risk within the broader context of sexual learning.